Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 8:44 PM
Study NCT ID:
NCT00892359
Status:
UNKNOWN
Last Update Posted:
2009-05-04
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077612', 'term': 'Anidulafungin'}], 'ancestors': [{'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-05-01', 'studyFirstSubmitDate': '2009-04-30', 'studyFirstSubmitQcDate': '2009-05-01', 'lastUpdatePostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'renal replacement therapy', 'hemofiltration', 'anidulafungin'], 'conditions': ['Acute Renal Failure', 'Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous venovenous hemofiltration.\n\nBackground: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of this class of antifungal agents are known to inhibit the synthesis of glucan polymers in fungal cell walls. The spectrum of activity of anidulafungin includes Candida (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.\n\nIn intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a well-established extracorporal renal replacement therapy with a high clearance rate.\n\nPharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF are rare. No data about anidulafungin in CVVHF are available although intensive care patients are perfect candidates for anidulafungin treatment due to their high risk profile for systemic fungal infections.\n\nStudy objective: The study is conducted to investigate the pharmacokinetics of anidulafungin during CVVHF in critically ill patients.\n\nStudy design: open, 1 arm\n\nStudy population: 10 critically ill adult patients administered to the ICU with acute renal failure and suspected or proven fungal infection.\n\nTreatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will be administered intravenously over 1.5 hours.\n\nMain outcome variables: The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.\n\nMethods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 to 70 years\n* Suspected or proven infection requiring parenteral antifungal therapy.\n* Continuous venovenous hemofiltration because of an acute renal failure.\n\nExclusion Criteria:\n\n* Known history of hypersensitivity to echinocandins.\n* An expected survival of less than three days.\n* Known alcohol dependency, epilepsy, pregnancy or liver failure.\n* Neutropenic patients'}, 'identificationModule': {'nctId': 'NCT00892359', 'briefTitle': 'Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration', 'orgStudyIdInfo': {'id': '1.1 - Leitner'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anidulafungin', 'interventionNames': ['Drug: Anidulafungin']}], 'interventions': [{'name': 'Anidulafungin', 'type': 'DRUG', 'description': 'treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.', 'armGroupLabels': ['Anidulafungin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Judith M Leitner, M.D.', 'role': 'CONTACT', 'email': 'judith.leitner@meduniwien.ac.at', 'phone': '+43140400'}, {'name': 'Judith M Leitner, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Judith M Leitner, M.D.', 'role': 'CONTACT', 'email': 'judith.leitner@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '4440'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Florian Thalhammer, M.D.', 'oldOrganization': 'Medical University of Vienna'}}}}